(113 days)
No
The summary describes a mechanical device (trauma screw) with a surface modification. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a trauma screw for bone reconstruction, osteotomy, arthrodesis, and joint fusion, which falls under the category of orthopedic fixation rather than a therapeutic device in the sense of delivering therapy, diagnosing, or preventing disease through non-mechanical or biological means. It is a mechanical implant.
No
The device description clearly states it is a "General trauma screw for compression and fixation of bone," and its intended use is for "bone reconstruction, osteotomy, arthrodesis, joint fusion." These are all therapeutic or reconstructive functions, not diagnostic ones.
No
The device description clearly indicates it is a physical trauma screw made of titanium and stainless steel, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bone reconstruction, osteotomy, arthrodesis, joint fusion." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "trauma screw for compression and fixation of bone." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used to treat a condition directly.
N/A
Intended Use / Indications for Use
The Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion appropriate for the device. The screw is intended for single use only.
A Tyber Medical BioTy™ Nanotopography Trauma Screw is designed to apply fixation between two adjacent segments of cortical and/or cancellous bone.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
General trauma screw for compression and fixation of bone. The BioTy™ Nanotopography provides a microscopic roughened surface with nano-scaled features. The screws will be provided sterile in both solid and cannulated form, made of from titanium and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing Summary: The following tests were performed to demonstrate that the Tyber Medical BioTy™ Nanotopography Trauma Screw is substantially equivalent to other predicate device.
Pull out Test per ASTM F543
Static Torsion Test per ASTM F543
Pyrogenicity testing was performed per ST72:2011
The results of these studies showed that the Tyber Medical BioTy™ Nanotopography Trauma Screw met the acceptance criteria.
Clinical Test Summary: n/a
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
Tyber Medical, LLC Mark Schenk Vice President Of Regulatory And Quality 83 S Commerce Way. Suite 310 Bethlehem. Pennsylvania 18017
Re: K170571
Trade/Device Name: Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 15, 2017 Received: May 16, 2017
Dear Mark Schenk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170571
Device Name
Tyber Medical BioTy" Nanotopography Trauma Screw, TyFix Screw
Indications for Use (Describe)
The Tyber Medical BioTy" Nanotopography Trauma Screw, TyFix Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion appropriate for the device. The screw is intended for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Traditional 510(k) Summary
as required by section 807.92(c).
Tyber Medical
BioTy™ Nanotopography Trauma Screw, TyFix Screw
K170571
| Submitted | 6/5/17 |
|---|---|
| Submitter: | Tyber Medical, LLC |
| 83 South Commerce Way, Ste 310 | |
| Bethlehem, PA 18017 | |
| Contact Person | Mark F Schenk |
| VP of QA/RA | |
| Phone: (610) 849-0645 Fax: (866) 889-9914 | |
| Email: mschenk@tybermed.com | |
| Trade Name | Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw |
| Common Name | Bone Compression Screw |
| Device Class | Class II |
| Classification Name | |
| and Number | Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3040 | |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | Tyber Medical BioTy™ Nanotopography Trauma Screw - K161597 |
| Tyber Medical Trauma Screw - K133842 | |
| Reference Predicate | Wright Medical PRO-TOE® - K120645 |
| Device Description | General trauma screw for compression and fixation of bone. The |
| BioTy™ Nanotopography provides a microscopic roughened surface | |
| with nano-scaled features. The screws will be provided sterile in both | |
| solid and cannulated form, made of from titanium and stainless steel. | |
| Intended Use | A Tyber Medical BioTy™ Nanotopography Trauma Screw is designed |
| to apply fixation between two adjacent segments of cortical and/or | |
| cancellous bone. | |
| Indications for Use | The Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix |
| Screw is indicated for use in bone reconstruction, osteotomy, | |
| arthrodesis, joint fusion appropriate for the size of the device. The | |
| screw is intended for single use only. | |
| Statement of | |
| Technological | |
| Comparison and | |
| Fundamental Scientific | |
| Technology | Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw |
| and its predicate device have the same indications for use and the | |
| same design on the threaded end of the device, and the same | |
| materials, technology and principles of operation and test results. |
This submission adds a barbed end that is a similar design, materials,
technology and principles of operation to the reference predicate. |
4
| Nonclinical Testing
Summary | The following tests were performed to demonstrate that the
Tyber Medical BioTy™ Nanotopography Trauma Screw is substantially
equivalent to other predicate device. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pull out Test per ASTM F543 Static Torsion Test per ASTM F543 Pyrogenicity testing was performed per ST72:2011 The results of these studies showed that the Tyber Medical BioTy™
Nanotopography Trauma Screw met the acceptance criteria. |
| Clinical Test Summary | n/a |
| Conclusion | Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw and its predicate devices have the same indications for use, similar design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. |
|---|---|
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |